Liver DiseasesNCT01381432
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
An observational study of Liver Diseases, run by GlaxoSmithKline.
Trial summary
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Azathioprine
- Type of treatment
- Pill or oral medicine
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The following subjects to whom azathioprine tablet is administered for "the suppression of lung transplant rejection"; 1. Subjects on whom lung transplantation is performed after approval and to whom azathioprine tablet is administered from transplant surgery to May 2010. 2. Subjects on whom lung transplantation is performed before approval and who have already completed the drug administeration as well as during the drug administration at the time of the contract terminiation.
Who may be able to join
- Subjects who undergo lung transplantation and azathioprine tablets were administered
Who cannot join
- Subjects with hypersensitivity to the ingredients of azathioprine tablet
- Subjects who is pregnant or might be pregnant
- Subjects whose white count is lower than 3000/cubic millimeter
About this study
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.
- Conditions
- Liver Diseases
- Being tested
- Azathioprine
- Keywords
- Antirejection
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
At the start of treatment, 2 to 3 mg per kg of body weight each day. For the rest of treatment, 1 to 2 mg per kg of body weight each day.
| Study group | Role | What they receive |
|---|---|---|
| Subjects prescribed azathioprine tablet | Subjects prescribed azathioprine tablet during study period after the lung transplantation Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events related to azathioprine tablets
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startDec 2004
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381432
- Sponsor's protocol ID
- 112314
- Status last verified
- May 2013
- First submitted
- 23 Jun 2011
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
- ClinicalTrials.gov ID
- NCT01381432
- Acronym / sponsor ID
- 112314
- Conditions
- Liver Diseases
- Keywords
- Antirejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed azathioprine tablet | – | Drug: AzathioprineSubjects prescribed azathioprine tablet during study period after the lung transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The following subjects to whom azathioprine tablet is administered for "the suppression of lung transplant rejection"; 1. Subjects on whom lung transplantation is performed after approval and to whom azathioprine tablet is administered from transplant surgery to May 2010. 2. Subjects on whom lung transplantation is performed before approval and who have already completed the drug administeration as well as during the drug administration at the time of the contract terminiation.
Key inclusion criteria (1 listed)
- Subjects who undergo lung transplantation and azathioprine tablets were administered
Key exclusion criteria (3 listed)
- Subjects with hypersensitivity to the ingredients of azathioprine tablet
- Subjects who is pregnant or might be pregnant
- Subjects whose white count is lower than 3000/cubic millimeter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzathioprineAt the start of treatment, 2 to 3 mg per kg of body weight each day. For the rest of treatment, 1 to 2 mg per kg of body weight each day. | Drug | Subjects prescribed azathioprine tablet |
Primary outcome
Incidence of adverse events related to azathioprine tablets
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events related to azathioprine tablets (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.